Company ยท US
Applications Lab
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1985. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 1985 | K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN Applications Lab | DEM |
| Mar 14, 1985 | K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M Applications Lab | DAO |
| Mar 5, 1985 | K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN Applications Lab | DEB |
| Mar 5, 1985 | K850589 | SPQ TEST SYSTEM FOR TRANSFERRIN Applications Lab | DDG |
| Mar 5, 1985 | K850588 | SPQ TEST SYSTEM FOR COMPLEMENT C3 Applications Lab | CZW |
| Mar 5, 1985 | K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN Applications Lab | DAD |
| Mar 1, 1985 | K850590 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN Applications Lab | DCK |
| Mar 1, 1985 | K850585 | SPQ TEST SYSTEM FOR COMPLEMENT C4 Applications Lab | DBI |
| Mar 1, 1985 | K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G Applications Lab | DEW |
| Mar 1, 1985 | K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A Applications Lab | CZP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||